Systems and methods for tissue adjustment

ABSTRACT

Apparatus is provided, including an implant including a tissue-adjusting member including a longitudinal member, and a tissue anchor coupled to the tissue-adjusting member and configured to be anchored into the tissue of the patient. A tissue-coupling element is coupled to the longitudinal member. A delivery tool is reversibly couplable to the implant and is configured to deliver the implant to the tissue of the patient. The delivery tool includes an elongate shaft, a tissue-coupling-element holder coupled to a portion of the elongate shaft, the tissue-coupling-element holder being configured to hold the tissue-coupling element during delivery of the implant to the tissue of the patient, and an actuating element configured to rotate the tissue anchor so as to facilitate anchoring of the tissue anchor into the tissue of the patient while not rotating the tissue-coupling-element holder with respect to the shaft.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/463,656 to Miller et al., filed Mar. 20, 2017, entitled,“Tool for actuating an adjusting mechanism,” which published as US2017/0209270 and which is a continuation of U.S. patent application Ser.No. 14/246,417 to Miller et al., filed Apr. 7, 2014, entitled, “Tool foractuating an adjusting mechanism,” which issued as U.S. Pat. No.9,622,861, and which is a continuation of U.S. patent application Ser.No. 12/926,673, to Miller et al., filed Dec. 2, 2010, entitled,“Delivery tool for implantation of spool assembly coupled to a helicalanchor,” which issued as U.S. Pat. No. 8,734,467, and which:

(a) claims priority from U.S. Provisional Application 61/265,936 toMiller et al., filed Dec. 2, 2009, entitled, “Delivery tool forimplantation of spool assembly coupled to a helical anchor;” and

(b) is related to PCT application PCT/IL2010/001024, entitled, “Deliverytool for implantation of spool assembly coupled to a helical anchor,”filed on Dec. 2, 2010, which published as WO 2011/067770.

All of these patents and applications are incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair. Morespecifically, the present invention relates to repair of anatrioventricular valve and a delivery tool therefor.

BACKGROUND

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

U.S. Pat. No. 7,431,692 to Zollinger et al. describes an adjustablesupport pad for adjustably holding a tensioning line used to applytension to a body organ. The adjustable support pad can include alocking mechanism for preventing slidable movement of the tensioningelement in one or both directions. The locking mechanism may includespring-loaded locks, rotatable cam-like structures, and/or rotatablespool structures. The adjustable support pad may be formed from rigid,semi-rigid, and/or flexible materials, and may be formed to conform tothe outer surface of a body organ. The adjustable support pad can beconfigured to adjustably hold one or more separate tensioning lines, andto provide for independent adjustment of one or more tensioning lines orgroups thereof.

US 2007/0118151 to Davidson describes a method and system to achieveleaflet coaptation in a cardiac valve percutaneously by creation ofneochordae to prolapsing valve segments. This technique is especiallyuseful in cases of ruptured chordae, but may be utilized in any segmentof prolapsing leaflet. The technique described herein has the additionaladvantage of being adjustable in the beating heart. This allowstailoring of leaflet coaptation height under various loading conditionsusing image-guidance, such as echocardiography. This offers anadditional distinct advantage over conventional open-surgery placementof artificial chordae. In traditional open surgical valve repair, chordlength must be estimated in the arrested heart and may or may not becorrect once the patient is weaned from cardiopulmonary bypass. Thetechnique described below also allows for placement of multipleartificial chordae, as dictated by the patient's pathophysiology.

U.S. Pat. No. 6,626,930 to Allen et al. describes apparatus and methodfor the stabilization and fastening of two pieces of tissue. A singledevice may be used to both stabilize and fasten the two pieces oftissue, or a separate stabilizing device may be used in conjunction witha fastening device. The stabilizing device may comprise a probe withvacuum ports and/or mechanical clamps disposed at the distal end toapproximate the two pieces of tissue. After the pieces of tissue arestabilized, they are fastened together using sutures or clips. Oneexemplary embodiment of a suture-based fastener comprises a toggle andsuture arrangement deployed by a needle, wherein the needle enters thefront side of the tissue and exits the blind side. In a second exemplaryembodiment, the suture-based fastener comprises a needle connected to asuture. The needle enters the blind side of the tissue and exits thefront side. The suture is then tied in a knot to secure the pieces oftissue. One example of a clip-based fastener comprises a spring-loadedclip having two arms with tapered distal ends and barbs. The probeincludes a deployment mechanism which causes the clip to pierce andlockingly secure the two pieces of tissue.

U.S. Pat. No. 6,629,534 to St. Goar et al. describes methods, devices,and systems are provided for performing endovascular repair ofatrioventricular and other cardiac valves in the heart. Regurgitation ofan atrioventricular valve, particularly a mitral valve, can be repairedby modifying a tissue structure selected from the valve leaflets, thevalve annulus, the valve chordae, and the papillary muscles. Thesestructures may be modified by suturing, stapling, snaring, orshortening, using interventional tools which are introduced to a heartchamber. Preferably, the tissue structures will be temporarily modifiedprior to permanent modification. For example, opposed valve leaflets maybe temporarily grasped and held into position prior to permanentattachment.

U.S. Pat. No. 6,752,813 to Goldfarb et al. describes methods and devicesfor grasping, and optional repositioning and fixation of the valveleaflets to treat cardiac valve regurgitation, particularly mitral valveregurgitation. Such grasping will typically be atraumatic providing anumber of benefits. For example, atraumatic grasping may allowrepositioning of the devices relative to the leaflets and repositioningof the leaflets themselves without damage to the leaflets. However, insome cases it may be necessary or desired to include grasping whichpierces or otherwise permanently affects the leaflets. In some of thesecases, the grasping step includes fixation.

US 2003/0105519 to Fasol et al. describes artificial chordae having astrand member and a first and second pair of sutures at eitherlongitudinal end of the strand member. The artificial chordae ispreferably a unitary unit, formed from inelastic flexible material. Inone embodiment, the artificial chordae comprises multiple strand membersjoined together at a joined end. Different sized artificial chordae areprovided sized to fit the patient's heart. The appropriately sizedartificial chordae is chosen by using a chordae sizing gauge having ashaft and a transverse member, to measure the space within the patient'sheart where the artificial chordae is attached.

The following patents and patent application publications may be ofinterest:

-   PCT Publication WO 07/136783 to Cartledge et al.-   U.S. Pat. No. 5,306,296 to Wright et al.-   U.S. Pat. No. 6,569,198 to Wilson et al.-   U.S. Pat. No. 6,619,291 to Hlavka et al.-   U.S. Pat. No. 6,764,510 to Vidlund et al.-   U.S. Pat. No. 7,004,176 to Lau-   U.S. Pat. No. 7,101,395 to Tremulis et al.-   U.S. Pat. No. 7,175,660 to Cartledge et al.-   US 2003/0050693 to Quijano et al-   US 2003/0167062 to Gambale et al.-   US 2004/0024451 to Johnson et al.-   US 2004/0148021 to Cartledge et al.-   US 2004/0236419 to Milo-   US 2005/0171601 to Cosgrove et al.-   US 2005/0216039 to Lederman-   US 2005/0288781 to Moaddeb et al.-   US 2007/0016287 to Cartledge et al.-   US 2007/0080188 to Spence et al.-   US 2009/0177266 to Powell et al.

The following articles may be of interest:

-   O'Reilly S et al., “Heart valve surgery pushes the envelope,”    Medtech Insight 8(3): 73, 99-108 (2006)-   Dieter R S, “Percutaneous valve repair: Update on mitral    regurgitation and endovascular approaches to the mitral valve,”    Applications in Imaging, Cardiac Interventions, Supported by an    educational grant from Amersham Health pp. 11-14 (2003)

SUMMARY OF THE INVENTION

In some applications of the present invention, a delivery tool isprovided for reversible coupling of a rotatable adjusting mechanismthereto, delivery of the adjusting mechanism to tissue of a patient, androtation of a rotatable structure of the adjusting mechanism. Typically,the adjusting mechanism is coupled to a tissue anchor and the deliverytool facilitates implantation of the adjusting mechanism in cardiactissue of the patient. The tool facilitates rotation of the adjustingmechanism in order to implant the tissue anchor, without rotating therotatable structure of the adjusting mechanism. Typically, the adjustingmechanism is coupled to an implant such as a tissue-adjusting member,e.g., one or more artificial chordae tendineae comprising one or moreflexible longitudinal members, and the adjusting mechanism facilitatestightening and loosening of the artificial chordae tendineae.Alternatively, the tissue-adjusting member comprises an annuloplastyring or a portion of a prosthetic valve. For such applications in whichthe tissue-adjusting member comprises an annuloplasty ring or at least aportion of a prosthetic valve, the tissue-adjusting member comprises aflexible contracting member that adjusts a dimension of at least aportion of the annuloplasty ring or at least a portion of the prostheticvalve.

Typically, the rotatable structure of the adjusting mechanism is shapedto define proximal and distal openings and a channel extending betweenthe proximal and distal openings. A proximal portion of an inner wall ofthe rotatable structure that surrounds the channel is shaped to define athreaded portion, e.g., a tapered threaded portion that decreases indiameter from the proximal opening.

Typically, the delivery tool has a distal end which is reversiblycouplable to the adjusting mechanism and comprises a manipulator, e.g.,a screwdriver tool. The manipulator is shaped to define a threadedportion that screws into the threaded portion of the rotatablestructure. The delivery tool comprises an ergonomic proximal handleportion that comprises at least two separate rotating members whichcontrol separate functions of the manipulator at the distal end of thetool. A proximal-most first knob rotates the manipulator sufficiently tocouple together the respective threaded portions of the manipulator andthe rotatable structure. A second knob that is distal to theproximal-most knob facilitates rotation of the manipulator sufficientlyto rotate the rotatable structure following the coupling of themanipulator to the rotatable structure. For some applications, thesecond knob is coupled to a visual indicator which indicates the numberof rotations of the screwdriver, and thereby, the number of rotations ofthe rotatable structure. Rotating the second knob in a first rotationaldirection rotates the second knob such that it advances distally along ahelical rotation path. The distal end of the helical rotation pathrestricts rotation of the second knob and thereby restricts rotation ofthe rotatable structure beyond a predetermined amount. A third knob,that is distal to the second knob, facilitates implantation by screwingof a tissue anchor adjusting mechanism in tissue of a patient withoutrotating the rotatable structure of the adjusting mechanism. Thus, thedelivery tool provides a single tool which (1) implants the adjustingmechanism in tissue of the patient by screwing the tissue anchor withoutrotating the rotatable structure of the adjusting mechanism, and (2)subsequently, but during a single advancement of the delivery tool,facilitates rotation of the rotatable structure of the adjustingmechanism without rotating the tissue anchor.

For some applications, the rotatable structure is coupled to a lockingmechanism which restricts rotation of the rotatable structure in aresting state of the locking mechanism. The delivery tool comprises anelongate locking mechanism release rod which is slidable within a lumenof the delivery tool in order to release the locking mechanism from therotatable structure prior to the rotating of the rotatable structureresponsively to the rotation of the second knob.

There is therefore provided, in accordance with some applications of thepresent invention, apparatus, including:

a tissue-adjusting member configured to be coupled to tissue of apatient;

a rotatable structure that is configured to adjust a tension of thetissue-adjusting member;

a tissue anchor coupled to the tissue-adjusting member and configured toscrew into the tissue of the patient; and

a delivery tool reversibly coupleable to the rotatable structure, thedelivery tool including:

-   -   a first actuating element configured to rotate the tissue anchor        so as to facilitate screwing of the tissue anchor into the        tissue of the patient while not facilitating rotation of the        rotatable structure; and    -   a second actuating element configured to rotate the rotatable        structure while not facilitating rotation of the tissue anchor.

In some applications of the present invention, the tissue anchorincludes a helical tissue anchor.

In some applications of the present invention:

the first actuating element includes a first rotatable knob,

the second actuating element includes a second rotatable knob,

the delivery tool has a longitudinal axis, and

the first and second rotatable knobs are configured to rotate about thelongitudinal axis of the delivery tool.

In some applications of the present invention, the apparatus furtherincludes a housing surrounding the rotatable structure, and the tissueanchor is coupled to the housing in a manner in which the rotatablestructure and the tissue anchor are disposed along the longitudinal axisof the delivery tool.

In some applications of the present invention, the tissue anchor and therotatable structure are disposed along the longitudinal axis of thedelivery tool.

In some applications of the present invention, the tissue anchor has atissue-anchor-axis-of-rotation that is along the longitudinal axis ofthe delivery tool, the rotatable structure has arotatable-structure-axis-of-rotation that is along the longitudinal axisof the delivery tool, and the tissue-anchor-axis-of-rotation and therotatable-structure-axis-of-rotation are identical.

In some applications of the present invention, the delivery toolincludes a first helical groove and a first pin, and the first pin ismechanically coupled to the first rotatable knob and advanceable withinthe first helical groove.

In some applications of the present invention, the delivery toolincludes a first cylindrical element that is shaped so as to define thefirst helical groove, and the first rotatable knob is coupled to thefirst cylindrical element in a manner in which, during rotation of thefirst rotatable knob, the first cylindrical element is configured torotate about the longitudinal axis of the delivery tool, and the firsthelical groove advances helically with respect to the first pin.

In some applications of the present invention, the first pin is coupledto a slidable numerical indicator, and, in response to advancement ofthe first helical groove helically with respect to the first pin, thefirst pin is advanceable linearly with respect to the delivery tool soas to indicate a number of rotations of the tissue anchor into thetissue of the patient.

In some applications of the present invention:

the cylindrical element is coupled to a proximal end of an elongatetube,

a distal end of the elongate tube is reversibly coupleable to the tissueanchor, and

during rotation of the first rotatable knob, the cylindrical elementrotates the elongate tube, and in turn, the elongate tube rotates thetissue anchor.

In some applications of the present invention:

the delivery tool further includes a torque-delivering tool reversiblycoupleable at a distal end thereof to the rotatable structure,

a proximal end of the torque-delivering tool is mechanically coupled tothe second rotatable knob,

the torque-delivering tool is disposed at least in part within the lumenof the elongate tube,

during rotation of the first rotatable knob, the torque-delivering toolis not rotated within the elongate tube, and thus, the rotatablestructure is not rotated.

In some applications of the present invention, in response to rotationof the second rotatable knob, the torque-delivering tool is rotatablewithin the lumen of the elongate tube, and responsively to the rotationof the torque-delivering tool within the lumen of the elongate tool, thetorque-delivering tool delivers torque to the rotatable structure inorder to rotate the rotatable structure.

In some applications of the present invention, the delivery toolincludes a second helical groove and a second pin, and the second pin ismechanically coupled to the second rotatable knob and advanceable withinthe second helical groove.

In some applications of the present invention, the delivery toolincludes a second cylindrical element that is shaped so as to define thesecond helical groove, and the second rotatable knob is coupled to thesecond pin in a manner in which, during rotation of the second rotatableknob, the second pin is rotatable about the longitudinal axis of thedelivery tool within the second helical groove.

In some applications of the present invention:

the delivery tool further includes a rotator coupled to the distal endof the torque-delivering tool,

second knob is mechanically coupled to the rotator and configured torotate the rotator in response to rotation of the second knob,

rotation of the rotator by the second knob rotates the torque-deliveringtool, and

rotation of the torque-delivering tool rotates the rotatable structure.

In some applications of the present invention, the second pin is coupledto a slidable indicator, and, in response to rotation of the second pinwithin the second helical groove, the slidable indicator is advanceablelinearly with respect to the delivery tool so as to indicate a number ofrotations of the rotatable structure.

In some applications of the present invention, the tissue-adjustingmember includes one or more artificial chordae tendineae coupled atleast in part to the rotatable structure, and rotation of the rotatablestructure adjusts a tension of the one or more chordae tendineae.

In some applications of the present invention, the apparatus furtherincludes a housing surrounding the rotatable structure, and the tissueanchor is coupled to the tissue-adjusting member via the housing.

In some applications of the present invention, at least a portion of theone or more chordae tendineae is looped through a portion of therotatable structure.

In some applications of the present invention, the apparatus furtherincludes a tissue-coupling element, each one of the one or more chordaetendineae has a free end, and the free end is coupled to thetissue-coupling element.

In some applications of the present invention, the delivery toolincludes a tissue-coupling element holder, and the at least a portion ofthe tissue-coupling element is disposable within the tissue-couplingelement holder during the screwing of the tissue anchor into the tissueof the patient.

In some applications of the present invention, the rotatable structureincludes a spool, and successive portions of the one or more chordaetendineae are configured to be wound around the spool responsively torotation of the second knob in a first rotational direction, and to beunwound from around the spool responsively to rotation of the secondknob in a second rotational direction that is opposite the firstrotational direction.

In some applications of the present invention, the delivery toolincludes a numerical indicator including a range of numbers configuredto indicate a number of times the one or more chordae tendineae arewound around the rotatable structure.

In some applications of the present invention:

prior to the screwing of the tissue anchor, at least a portion of theone or more chordae tendineae is wound around a portion of the rotatablestructure, and

the numerical indicator includes a range of numbers indicating a numberof times the one or more chordae tendineae are wound around therotatable structure prior to the screwing of the tissue anchor.

In some applications of the present invention, the delivery tool furtherincludes a rotatable-structure-manipulator, and therotatable-structure-manipulator is coupled to the distal end of thetorque-delivering tool.

In some applications of the present invention, a portion of therotatable structure is shaped so as to define a first threaded portion,a portion of the rotatable-structure-manipulator is shaped so as todefine a second threaded portion, and therotatable-structure-manipulator is reversibly couplable to the rotatablestructure when the second threaded portion is screwed with respect tothe first threaded portion.

In some applications of the present invention, the rotatable structure:

includes a first end shaped to define a first opening,

includes a second end having a lower surface shaped so as to define asecond opening of the rotatable structure,

is shaped so as to define a channel extending from the first opening tothe second opening, and

is shaped so as to define a first coupling at the lower surface of thesecond end thereof, and the apparatus further includes:

-   -   a mechanical element having a surface coupled to the lower        surface of the rotatable structure, the mechanical element being        shaped to provide:        -   a second coupling configured to engage the first coupling            during a resting state of the mechanical element, in a            manner that restricts rotation of the rotatable structure,            and        -   a depressible portion coupled to the protrusion, the            depressible portion being disposed in communication with the            second opening of the lower surface, and configured to            disengage the first and second couplings.

In some applications of the present invention, the delivery toolincludes an elongate release rod configured to depress the depressibleportion and to release the rotatable structure by disengaging the secondcoupling from the first coupling.

In some applications of the present invention, the torque-deliveringtool is shaped so as to define a torque-delivering tool lumen forslidable passage therethrough of the elongate release rod.

There is further provided, in accordance with some applications of thepresent invention, a method, including:

using a delivery tool, advancing toward tissue of a patient, atissue-adjusting member coupled to a tissue anchor and a rotatablestructure that is configured to adjust a tension of the tissue-adjustingmember;

implanting the tissue anchor in the tissue of the patient by screwingthe tissue anchor into the tissue by actuating a first actuating elementof the delivery tool, while not rotating the rotatable structure; and

subsequently to the implanting, rotating the rotatable structure byactuating a second actuating element of the delivery tool, while notrotating the tissue anchor.

In some applications of the present invention, the screwing of thetissue anchor and the subsequent rotating of the rotatable structureoccur during a single advancing using the delivery tool.

In some applications of the present invention, the screwing of thetissue anchor includes screwing the tissue anchor along an axis ofrotation, and rotating the rotatable structure includes rotating therotating structure along the axis of rotation without moving thedelivery tool from the axis of rotation.

In some applications of the present invention, advancing toward thetissue of the patient includes advancing at least a distal portion ofthe delivery tool into a body cavity of the patient, and the screwing ofthe tissue anchor and the subsequent rotating of the rotatable structureoccur without extracting the distal portion of the delivery tool fromwithin the body cavity.

In some applications of the present invention:

the tissue-adjusting member includes one or more artificial chordaetendineae,

implanting the tissue anchor in the tissue includes implanting thetissue anchor in a portion of tissue of a ventricle of a heart of thepatient, and

the method further includes coupling at least one free end of the one ormore chordae tendineae to at least one native leaflet of a nativeatrioventricular valve.

In some applications of the present invention, rotating the rotatablestructure includes rotating the rotatable structure subsequently to thecoupling to the at least one leaflet of the at least one free end of theone or more chordae tendineae.

In some applications of the present invention, rotating the rotatablestructure includes adjusting a tension of the one or more chordaetendineae.

In some applications of the present invention, advancing thetissue-adjusting member includes advancing the tissue-adjusting memberin a manner in which a portion of the one or more chordae tendineae iswound around a portion of the rotatable structure, and adjusting atension of the one or more chordae tendineae includes unwinding theportion of the one or more chordae tendineae from around the rotatablestructure subsequently to the coupling to the at least one leaflet ofthe at least one free end of the one or more chordae tendineae.

In some applications of the present invention, adjusting the tension ofthe one or more chordae tendineae includes winding successive portionsof the one or more chordae tendineae around the rotatable structure byrotating the rotatable structure in a first rotational direction.

In some applications of the present invention, adjusting the tension ofthe one or more chordae tendineae includes unwinding the successiveportions of the one or more chordae tendineae from around the rotatablestructure by rotating the rotatable structure in a second rotationaldirection that is opposite the first rotational direction.

There is additionally provided, in accordance with some applications ofthe present invention, apparatus, including:

a rotatable structure having a first end shaped to define a firstopening, and a second end shaped to define a second opening and having alower surface thereof, the rotatable structure being shaped to define:

-   -   a channel extending from the first opening to the second        opening, and    -   a first coupling at the lower surface of the second end thereof;

a mechanical element having a surface coupled to the lower surface ofthe rotatable structure, the mechanical element being shaped to provide:

-   -   a second coupling configured to engage the first coupling during        a resting state of the mechanical element, in a manner that        restricts rotation of the rotatable structure, and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to disengage the first and        second couplings;

a helical anchor coupled to the rotatable structure; and

a delivery tool configured to deliver the rotatable structure to atissue site of a patient, the delivery tool including:

-   -   at least a first rotatable knob;    -   a torque-delivering tool coupled to the first rotatable knob,        the torque-delivering tool being shaped to define a        torque-delivering-tool lumen;    -   a screwdriver head coupled to the torque-delivering tool at a        distal end thereof, the screwdriver head being shaped to define        a screwdriver head and configured to rotate the rotatable        structure in response to toque delivered to the screwdriver head        by the torque-delivering tool in response to rotation of the        first rotatable knob; and    -   an elongate tool coupled to the knob at a proximal end, the        elongate tool being slidably coupled to the delivery tool and        disposed at least in part within the torque-delivering-tool        lumen, the elongate tool:        -   having a proximal end coupled to the first rotatable knob            and,        -   having a distal end thereof being advanceable distally,            responsively to a distal pushing of the first rotatable            knob, through the screwdriver head lumen and through the            channel of the rotatable structure, the distal end of the            elongate tool being configured to move the depressible            portion in a manner in which the elongate tool disengages            the first and second couplings.

There is additionally provided, in accordance with some applications ofthe present invention, a method, including:

coupling a delivery tool to a rotatable structure by rotating arotatable knob of the delivery tool and screwing a screwdriver head ofthe delivery tool to a proximal portion the rotatable structure withoutrotating the rotatable structure, the rotatable structure having a firstend shaped to define a first opening, and a second end shaped to definea second opening and having a lower surface thereof, the rotatablestructure being shaped to define a channel extending from the firstopening to the second opening, and at least one first coupling at thelower surface of the second end thereof,

subsequently to the coupling, disengaging a second coupling from withinthe at least one first coupling of the rotatable structure by:

-   -   pushing distally the rotatable knob,    -   pushing distally a distal end of an elongate tool through the        channel of the rotatable structure and beyond the second opening        of the rotatable structure,    -   responsively to the pushing distally of the distal end of the        elongate tool, moving a depressible portion that is coupled to        the second coupling and disposed in communication with the        second opening of the lower surface of the rotatable structure;        and

subsequently to the disengaging, rotating the rotatable structure byrotating at least a portion of the delivery tool.

There is further provided, in accordance with some applications of thepresent invention, apparatus for adjusting at least one dimension of animplant, including:

a rotatable structure having a first end shaped to define a firstopening, and a second end shaped to define a second opening and having alower surface thereof, the rotatable structure being shaped to define:

-   -   a channel extending from the first opening to the second        opening, the channel being configured for passage therethrough        of an elongate tool, and    -   at least one first coupling at the lower surface of the second        end thereof; and

a mechanical element having a surface coupled to the lower surface ofthe rotatable structure, the mechanical element being shaped to provide:

-   -   a second coupling configured to engage the first coupling during        a resting state of the mechanical element, in a manner that        restricts rotation of the rotatable structure, and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to disengage the at least        one first coupling and the second coupling in response to a        force applied thereto by the elongate tool.

There is also provided, in accordance with some applications of thepresent invention, a method, including:

providing a rotatable structure, and a mechanical locking element thatis coupled to a lower surface of the rotatable structure;

implanting the rotatable structure in cardiac tissue;

advancing an elongate tool through a channel provided by the rotatablestructure;

unlocking the rotatable structure from the mechanical locking element bypushing a depressible portion of the locking element;

responsively to the pushing of the depressible portion, dislodging afirst coupling provided by the rotatable structure from a secondcoupling provided by the mechanical element; and

in response to the dislodging, rotating the rotatable structure.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a delivery tool which facilitatesimplantation and rotation of a rotatable structure in an adjustingmechanism, in accordance with some applications of the presentinvention;

FIG. 2 is a schematic illustration of the delivery tool of FIG. 1coupled to the adjusting mechanism, in accordance with some applicationsof the present invention;

FIGS. 3A-B are schematic cross-sectional illustrations of the deliverytool of FIG. 1 , in accordance with some applications of the presentinvention; and

FIG. 4 is a schematic illustration of the delivery tool of FIG. 1implanting the adjusting mechanism in a heart of a patient, inaccordance with some applications of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Reference is made to FIGS. 1 and 2 . FIG. 1 is a schematic illustrationof a system 3000 comprising a delivery tool 3022 for (1) delivering andimplanting a tissue anchor and an adjusting mechanism 40 coupledthereto, mechanism 40 comprising a rotatable structure 2900, e.g., aspool 3046, to tissue of a patient, and (2) facilitating rotation of therotatable structure, in accordance with some applications of the presentinvention. FIG. 2 shows delivery tool 3022 coupled at a distal portion3028 thereof to adjusting mechanism 40 and artificial chordae tendineaecomprising respective portions 60A and 60B of a tissue-adjusting member(e.g., flexible longitudinal member 60), in accordance with someapplications of the present invention. Typically, the longitudinalmember is looped through the spool of rotatable structure 2900 anddefines portions 60A and 60B of member 60. It is to be noted thatalthough the spool of rotatable structure 2900 is described herein asbeing coupled to one flexible longitudinal member, the spool may becoupled to any number of longitudinal members which function asartificial chordae tendineae.

FIG. 1 is an exploded view of tool 3022 showing the relationship of itscomponents. Tool 3022 has an elongate shaft 22 and a proximal handleportion 3026. For some applications, and as shown herein, shaft 22comprises a multilumen shaft, by way of illustration and not limitation.For some applications, shaft 22 may be shaped to define only a singlecentral lumen for passage therethrough of a torque-delivering tool 26.Typically, shaft 22 is sized for open-heart and/or minimally-invasiveprocedures and comprises a flexible material (e.g., a plastic or aplurality of strands of flexible metal such as stainless steel that arebundled together) which may be bent to a desired angle. For someapplications shaft 22 is sized for transluminal, percutaneous, orendovascular procedures for delivery of adjusting mechanism 40 coupledto portions 60A and 60B of flexible longitudinal member 60 (labeled inFIG. 2 ), as described herein.

(In this context, in the specification and in the claims, “proximal”means closer to the orifice through which system 3000 is originallyplaced into the body of the patient, and “distal” means further fromthis orifice.)

Proximal handle portion 3026 is shaped to define an ergonomichand-grasping portion 3120 for the physician to grasp and thereby holdtool 3022. A proximal end portion of shaft 22 is coupled to handleportion 3026, such as by being disposed within a lumen of handle portion3026.

A distal end portion 3028 of shaft 22 is coupled to, e.g., welded to, anadjusting mechanism holder 3029 having a distal end that is reversiblycoupled to adjusting mechanism 40, such as to a proximal portion of ahousing 3342 (labeled in FIG. 2 ) surrounding the rotatable structure ofadjusting mechanism 40, described hereinbelow with reference to FIG. 2 .Shaft 22 is shaped to define a central lumen through whichtorque-delivering tool 26 passes. A proximal end of torque-deliveringtool 26 is coupled to the rotating mechanism at proximal handle portion3026. Shaft 22 is shaped to define a central lumen through whichtorque-delivering tool 26 passes.

Reference is again made to FIG. 2 , which shows distal portion 3028 oftool 3022 coupled to adjusting mechanism 40. For some applications,adjusting mechanism 40 comprises rotatable structure housing 3342 whichhouses rotatable structure 2900. Housing 3342 is coupled at a distal endportion thereof to a tissue anchor 50. Anchor 50 has a pointed distaltip 52 for penetrating cardiac tissue, thereby coupling the anchor tothe tissue. Housing 3342 and anchor 50 collectively define a spoolassembly 240. Tissue anchor 50 is shown as a helical anchor by way ofillustration and not limitation, and may instead be spiral (e.g., havingthe shape of a corkscrew), shaped so as to define a screw thread, orhave another shape that facilitates coupling of the anchor to cardiactissue upon rotation of the anchor. Alternatively or additionally,anchor 50 may comprise staples, clips, spring-loaded anchors, or othertissue anchors known in the art. For some applications, rotatablestructure 2900 comprises a spool (i.e., spool 3046, as shown hereinbelowin FIGS. 3A-B), by way of illustration and not limitation. It is to benoted that rotatable structure 2900 may comprise any suitable rotatablestructure known in the art. Rotatable structure 2900 and knobs 3070 and3090 typically rotate about a central axis 3300 of tool 3022. As shown(especially in FIGS. 3A-B), housing 3342, spool 3046, and tissue anchorare disposed along axis 3300 of tool 3022.

Adjusting mechanism 40 functions to adjust a dimension of the artificialchordae tendineae, i.e., portions 60A and 60B of longitudinal member 60.Such techniques for artificial chordal adjustment may be implementedusing any one of the techniques described in US 2010/0161042 to Maisanoet al., which issued as U.S. Pat. No. 8,808,368, and which isincorporated herein by reference. It is to be noted that any number oflongitudinal members 60 may be coupled to adjusting mechanism 40.

FIG. 2 shows delivery tool 3022 in its assembled state. System 3000typically comprises portions 60A and 60B of flexible, longitudinalmember 60 which function as the repair chords that are ultimatelyimplanted in the heart of the patient. A portion of longitudinal member60 that is between portions 60A and 60B of the longitudinal member iscoupled by being looped through one or more holes in the spool that ishoused within spool housing 3342. Typically, each one of the respectivefree ends of portions 60A and 60B of longitudinal member 60 is coupledto a tissue-coupling element (e.g., a suture needle 64). For someapplications, a portion of shaft 22 is surrounded by a needle holder 70which is shaped so as to define an engaging component 3030. Component3030 is typically shaped to define generally planar blades 3032. Forsome applications, each blade 3032 has at least one respective slit 3160and 3162. Each slit 3160 and 3162 may house a respective needle 64.

Spool housing 3342 is shaped so as to define respective conduits 3320and 3322 through which portions 60A and 60B of longitudinal member 60enter housing 3342 and pass toward the spool disposed within housing3342. Each portion 60A and 60B of longitudinal member 60 extends fromthe spool disposed within housing 3342, through a respective secondarylumen 192 of multilumen shaft 22 (as shown in the transversecross-section of shaft 22) toward needle holder 70. During delivery ofspool assembly 240 to the implantation site in the ventricle of thepatient, needles 64 are disposed within slits 3160 and 3162 of needleholder 70 so as to facilitate atraumatic delivery of spool assembly 240to the implantation site. During the coupling of portions 60A and 60B oflongitudinal member 60 in the heart of the patient, needles 64 areextracted from within respective slits 3160 and 3162 and portions 60Aand 60B of longitudinal member 60 are sutured to cardiac tissue (e.g., asingle leaflet of an atrioventricular valve, respective first and secondleaflets of the atrioventricular valve, or to a portion of the ventriclewall) that faces and surrounds the ventricular lumen of the heart.

Typically, longitudinal member 60 comprises a flexible and/orsuperelastic material, e.g., ePTFE, nitinol, PTFE, polyester, stainlesssteel, or cobalt chrome. In some applications, longitudinal member 60 iscoated with polytetrafluoroethylene (PTFE) or with PTFE. In otherapplications, longitudinal member 60 comprises at least one wire/sutureportion and at least one portion that comprises an elongate tensioningcoil. For example, portions 60A and 60B of longitudinal member 60 maycomprise an elongate coil between two wire/suture portions.

For some applications, following the initial procedure of implantationand adjustment of the artificial chordae tendineae, the respectivelengths of portions 60A and 60B of longitudinal member 60 may beadjusted (either shortened or lengthened) from a site outside thepatient's body (i.e., immediately following the procedure or during asubsequent procedure). For example, the length may be adjusted byapplying RF or ultrasound energy to the members.

For some applications, shaft 22 defines longitudinal slits 122 that runparallel to longitudinal axis 3300 of tool 3022. Once spool assembly 240is implanted in cardiac tissue (as described hereinbelow), each needle64 is decoupled from respective slits 3160 and 3162 of needle holder 70and portions 60A and 60B of longitudinal member are pulled from withinlumens 192, via slits 122, and away from longitudinal axis 3300 of tool3022 in order to release portions 60A and 60B from within shaft 22.

For some applications, one or more guide wires (not shown for clarity ofillustration) are (1) coupled at respective first ends thereof to spoolhousing 3342, (2) extend through respective secondary lumens 194 ofmultilumen shaft 22, and (3) are coupled at respective second endsthereof to handle portion 3026. Technique for use the guidewires may bepracticed in combination with techniques described in above-mentioned US2010/0161042 to Maisano et al. In such an application, followingimplantation and adjustment of the repair chords, as describedhereinbelow, the guide wires may be cut and pulled away from housing3342. For other applications, the guide wires are reversibly coupled tohousing 3342 by being looped through a portion of the housing. In theseapplications, following implantation and adjustment of the repairchords, as described hereinbelow, the guide wires may be pulled awayfrom housing 3342. For yet other applications, the guide wires remaindisposed within the body of the patient and are accessible at a laterstage by an access-port system.

Reference is now made to FIGS. 3A-B, which are schematic cross-sectionalillustrations of tool 3022 coupled to adjusting mechanism 40 comprisingrotatable structure 2900 (e.g., spool 3046), in accordance with someapplications of the present invention. Adjusting mechanism 40 is shownas comprising housing 3342 which defines a recessed portion 142. FIG. 3Ashows spool 3046 prior to rotation thereof. As shown in the enlargedimage, a portion of longitudinal member 60 is wound a few times (e.g., 3times, as shown) around the cylindrical body portion of spool 3046.Prior to rotation of spool 3046, portions 60A and 60B of longitudinalmember 60 are in a slackened state and longitudinal member 60 iswrapped, or wound, a few times (e.g., 3 times, as shown) around thecylindrical portion of spool 3046, as shown in FIG. 3A.

FIG. 3B shows spool 3046 following rotation thereof. As describedhereinabove, adjusting mechanism holder 3029 has a distal end that isreversibly coupled to adjusting mechanism 40, such as to a proximalportion of a housing 3342 surrounding the rotatable structure ofadjusting mechanism 40. Holder 3029 is shaped to define a lumen forslidable passage therethrough of a manipulator 3040 which comprises adistal screwdriver head 3042. Screwdriver head 3042 is coupled torotatable structure 2900 and facilitates rotation of rotatable structure2900 responsively to the rotation of manipulator 3040. Manipulator 3040is coupled at a proximal end thereof to a distal end oftorque-delivering tool 26 which delivers torque to manipulator 3040 andeffects rotation of screwdriver head 3042. As is described herein, aproximal end of torque-delivering tool 26 is coupled to the rotatingmechanism at proximal handle portion 3026.

Adjusting mechanism holder 3029 comprises distal graspers 3330 whichreversibly couple holder 3029 to adjusting mechanism 40 by grasping aproximal male projection 3346 of spool 3046. Graspers 3330 have atendency to compress toward one another, and thus are reversibly clampedaround proximal projection 3346 of spool 3046.

As shown in the enlarged image, longitudinal member 60 is further woundaround spool 3046 a few more times (e.g., an additional 4 times, asshown) around the cylindrical body portion of spool 3046. The rotationof spool 3046 pulls taut portions 60A and 60B of longitudinal member 60.

Rotation of spool 3046 in a first direction winds the longitudinalmember 60 around spool 3046, while rotation of spool 3046 in a seconddirection opposite the first direction, unwinds the portion oflongitudinal member 60 from around spool 3046.

Spool 3046 defines an upper surface 150, a lower surface 152 and acylindrical body portion disposed vertically between surfaces 150 and152. Spool 3046 is shaped to provide a driving interface, e.g., achannel, which extends from a first opening provided by upper surface150 to a second opening provided by lower surface 152. A proximalportion of the driving interface is shaped to define a threaded portion2046 which may or may not be tapered. The cylindrical body portion ofspool 3046 is shaped to define one or more holes which function asrespective coupling sites for coupling (e.g., looping through the one ormore holes, or welding to spool 3046 in the vicinity of the one or moreholes) of any number of longitudinal members 60 to spool 3046.

Lower surface 152 of spool 3046 is shaped to define one or more (e.g., aplurality, as shown) recesses 154 which define structural barrierportions of lower surface 152. It is to be noted that any suitablenumber of recesses 154 may be provided, e.g., between 1 and 10 recesses,(e.g., circumferentially with respect to lower surface 152 of spool3046).

Reference is still made to FIGS. 3A-B. For some applications, adjustingmechanism 40 comprises a locking mechanism 45, which is disposed incommunication with lower surface 152 of spool 3046 and disposed incommunication with at least in part to a lower surface of spool housing3342. Locking mechanism 45 comprises a mechanical element which has apushed state (FIG. 3A) and a resting state (FIG. 3B). Typically, a cap44 maintains locking mechanism 45 in place with respect to lower surface152 of spool 3046 and lower surface of spool housing 3342. For someapplications, locking mechanism 45 is coupled, e.g., welded, to thelower surface of housing 3342. Typically, locking mechanism 45 definesslits. It is to be noted that the surface of locking mechanism 45 mayalso be curved, and not planar. Locking mechanism 45 is shaped toprovide a protrusion 156 (or a coupling) which projects out of a planedefined by the planar surface of the mechanical element of lockingmechanism 45. The slits of mechanism 45 define a depressible portion 128that is disposed in communication with and extends toward protrusion156. Depressible portion 128 is moveable in response to a force appliedthereto typically by an elongate locking mechanism release rod 3060which slides through a lumen of torque-delivering tool 26.

It is to be noted that the planar, mechanical element of lockingmechanism 45 is shown by way of illustration and not limitation and thatany suitable mechanical element having or lacking a planar surface butshaped to define at least one protrusion may be used together withlocking mechanism 45.

For some applications, cap 44 is shaped to define a planar surface andan annular wall having an upper surface thereof. The upper surface ofthe annular wall is coupled to, e.g., welded to, a lower surfaceprovided by spool housing 3342. The annular wall of cap 44 is shaped todefine a recessed portion 144 of cap 44 that is in alignment withrecessed portion 142 of spool housing 3342.

Reference is now made to FIG. 4 , which is a schematic illustration oftool 3022 facilitating implantation of anchor 50 of spool assembly 240in cardiac tissue and adjustment of longitudinal member 60 functioningas artificial chords, in accordance with some applications of thepresent invention. Following implantation of anchor 50, tool 3022facilitates rotation of the spool of adjusting mechanism 40.

It is to be noted that although adjusting of artificial chords in orderto repair mitral valve 8 is shown herein, system 3000 may additionallybe used to implant and adjust artificial chords in order to repair atricuspid valve of the patient.

Spool housing 3342 is typically surrounded by a braided fabric mesh,e.g., a braided polyester mesh, which promotes fibrosis around assembly240 over time subsequently to the implantation of assembly 240 and theadjustment of longitudinal member 60. Additionally, during the initialimplantation of assembly 240, spool housing 3342 may be sutured via themesh to the cardiac tissue (e.g., during an open-heart procedure).

Reference is now made to FIGS. 1, 3A-B, and 4. Prior to rotating spool3046, anchor 50 of assembly 240 is implanted at an implantation site atcardiac tissue of the patient, e.g., a papillary muscle 4 (as shown) ora portion of tissue of an inner wall of the ventricle (e.g., a portionof the wall in a vicinity of the apex, a portion of a free wall, or aportion of the wall in a vicinity of the septum). Implantation of spoolassembly 240 is facilitated by tool 3022. An incision is made in heart2, and tissue anchor 50, adjusting mechanism 40, longitudinal member 60,and a distal portion of shaft 22 are advanced between leaflets 12 and 14of mitral valve 8 and toward papillary muscle 4. Assembly 240 isadvanced until pointed tip 52 of anchor 50 abuts papillary muscle 4. Aknob 3202 is rotated in a first rotational direction in order to rotatehousing 3342 and anchor 50 in a first rotational direction withoutrotating spool 3046 disposed within assembly 240 (i.e., spool 3046 isnot rotated relative to housing 3342 in response to rotation of housing3342 and anchor 50).

As shown in FIG. 1 , knob 3202 is coupled to a structural component 3200(i.e., a distal portion of knob 3202 is fixed to a proximal portion ofcomponent 3200). As knob 3202 is rotated, component 3200 is rotated,which rotates shaft 22 that is coupled at a proximal end thereof to adistal portion of handle portion 3026. Shaft 22, in turn, surrounds andfacilitates slidable coupled of an overtube 90, which in turn, surroundstorque-delivering tool 26 (as shown in the enlarged cross-sectionalimages of FIGS. 3A-B). Overtube 90 is coupled at a distal end thereof toadjusting mechanism holder 3029.

Rotation of knob 3202 rotates shaft 22, and thereby overtube 90 isrotated, which rotates holder 3029 and thereby rotates anchor 50 andhousing 3342 of spool assembly 240. During rotation of overtube 90,torque-delivering tool 26 is not rotated within the lumen of overtube90. Therefore, spool 3046 is not rotated with respect to spool housing3342 as knob 3202 is rotated in order to rotate anchor 50 and housing3342 of spool assembly 240. Spool 3046 is not rotated within housing3342 with respect to tissue anchor 50 or housing 3342 becausetorque-delivering tool 26 is not rotated relative to tool 3022.(Rotation of spool 3046, with respect to housing 3342, occurssubsequently to rotation of tissue anchor 50 and housing 3342 ofassembly 240 and responsively to rotation of torque-delivering tool 26in order to rotate manipulator 3040 and thereby spool 3046. During suchrotation of spool 3046, tissue anchor 50 and housing 3342 are notrotated.) Rotation of knob 3202 screws anchor 50 into cardiac tissue ofthe patient, and thereby implants spool assembly 240 in the ventricle ofheart 2. During the screwing of anchor 50 into cardiac tissue, spool3046 is not rotated with respect to housing 3342 so as to preventmanipulation of the tension of flexible longitudinal member 60 at thesame time that spool assembly 240 is being implanted in heart 2.

Reference is again made to FIG. 1 . For some applications, knob 3202 iscoupled to structural component 3200, which is shaped so as to define ahelical groove 3260 having a distal end 3262. Groove 3260 provides atrack 3263 for advancement of a pin 3064 therealong. Prior to rotationof knob 3202, pin 3064 is disposed at a proximal end portion of groove3260. As knob 3202 is rotated in a first direction, component 3200 isrotated in the first direction while pin 3064 remains in place.Component 3200 advances with respect to pin 3064 as groove 3260 advancesaround pin 3064. Concurrently, pin 3064 advances linearly distally withrespect to hand-grasping portion 3120 that defines a slit 3067 alongwhich pin 3064 advances distally. Pin 3064 is coupled to lateralprojection 3068 of a slidable numerical indicator 3066. Indicator 3066is configured to remotely indicate the number of rotations of tissueanchor 50 during the screwing of assembly 240 into tissue of thepatient.

As pin 3064 distally advances linearly along slit 3067, indicator 3066advances linearly along a track provided by an undersurface of a cover3182 that is coupled to hand-grasping portion 3120 and covers slit 3067.Cover 3182 remains stationary as indicator 3066 advances linearly withrespect to cover 3182. Cover 3182 is shaped so as to define a window3180 which displays a number of the series of numbers of indicator 3066as it advances linearly with respect to cover 3182. This numberindicates the number of rotations of assembly 240. As knob 3202 isrotated, a distal end 3262 of groove 3260 approaches pin 3064, andindicator 3066 indicates a higher number in the series of numbers. Oncedistal end 3262 of groove 3260 contacts pin 3064, rotation of knob 3202,and thereby rotation of spool assembly 240, is restricted. That is, tool3022 restricts implantation of anchor 50 beyond a predetermined amountof rotations (e.g., 4 rotations as indicated by indicator 3066) in orderto prevent over-screwing of assembly 240 into tissue.

Rotation of knob 3202 in a second direction, opposite the first, causescomponent 3200 to rotate in the second direction. Rotation of component3200 in the second direction rotates overtube 90 and holder 3029 in thesecond direction, and responsively, tissue anchor 50 of spool assembly240 is unscrewed from the tissue. Additionally, pin 3064 is advancedproximally as groove 3260 slides around pin 3064. Pin 3064 thus causesindicator 3066 to indicate a lower number in the series of numbers.

Reference is again made to FIG. 4 . Following implantation of assembly240, portions 60A and 60B of longitudinal member 60 are coupled (e.g.,sutured, knotted, or otherwise fastened) to leaflet 12. As shown,portions 60A and 60 may be knotted to leaflet 12 via knot 67. Theadjusting of adjusting mechanism 40 functions to generally returnleaflet 12 to its physiological state and provide artificial chordaetendineae. For some applications, first portion 60A may be coupled toleaflet 12 while second portion 60B may be coupled to leaflet 14. Insuch applications, the adjusting of adjusting mechanism 40 may functionto draw together leaflets 12 and 14.

Prior to coupling of portions 60A and 60B to leaflet 12, as shown (or toboth leaflets 12 and 14), shaft 22 is slid proximally along overtube 90such that a distal end thereof is disposed proximally to mitral valve 8in the atrium of heart 2 (as shown in FIG. 4 ).

Reference is now made to FIGS. 1, 3A, and 4 . As shown in FIG. 3A, adistal end of shaft 22 is coupled to a shaft-coupler 3027 (and fastenedthereto by a fastener 3025). Shaft-coupler 3027 slides along a slit 3024of a portion of handle portion 3026 (shown in FIG. 1 ) which defines alumen 3023 for passage therethrough of a proximal portion of shaft 22.The operating physician pulls proximally on holder 70 that surrounds aportion of shaft 22. As holder 70 is pulled, shaft 22 is slid proximallysuch that a proximal portion thereof is slid into lumen 3023 of handleportion 3026. Alternatively or additionally, the physician may pullproximally on a portion of shaft 22 by grabbing a portion of shaft 22.The sliding of shaft 22 proximally exposes a proximal portion ofovertube 90 (shown in FIG. 4 ). Sliding of shaft 22 thus reduces thediameter of the portion of tool 3022 that is disposed between leaflets12 and 14, and thus, reduces interference of tool 3022 on the beating ofvalve 8 as portions 60A and 60B of longitudinal member 60 are adjusted.

Reference is now made to FIGS. 2 and 4 . Following the sliding of shaft22, needles 64 are removed from slits 3160 and 3162 of holder 70 andpulled so that the pulling of respective needles 64 pulls portions 60Aand 60B of longitudinal member 60 from within lumens 192 of shaft 22(i.e., via slits 122 of shaft 22 that extend along shaft 22 towardholder 70). Needles 64 are used to suture portions 60A and 60B toleaflet 12, and then portions 60A and 60B are clipped proximally to knot67 and excess portions of longitudinal members 60 (as shown in FIG. 4 ),and needles 64 are removed from heart 2. The incision in heart 2 is thenclosed around shaft 22, e.g., using a purse-string stitch, and thepatient is removed from the cardiopulmonary bypass pump so that heart 2resumes beating during the subsequent adjustment of portions 60A and 60Bby rotation of spool 3046 of adjusting mechanism 40.

Reference is again made to FIGS. 3A-B. FIG. 3A shows adjusting mechanism40 in an unlocked configuration in which protrusion 156 of lockingmechanism 45 is disposed within recessed portion 144 of cap 44. FIG. 3Bshows adjusting mechanism 40 in a locked state thereof due to thepositioning of protrusion 156 within a recess 154 of spool 3046.

Manipulator 3040, comprising screwdriver head 3042, is coupled to thedistal end of torque-delivering tool 26. A proximal end oftorque-delivering tool 26 is coupled to a rotating mechanism in proximalhandle portion 3026 of tool 3022. The rotating mechanism comprises atorque-delivering-tool rotator 3080 which is rotated at different timesduring a surgical procedure by knobs 3070 and 3090.Torque-delivering-tool rotator 3080 comprises a cylindrical structurewhich is shaped to define a lumen 3077 (shown in FIG. 3B) and an openingat a proximal end thereof. Lumen 3077 of rotator 3080 provides aslidable coupling arrangement for an elongate structural component 3071that is coupled to knob 3070. One or more pins 3084 (e.g., 1 pin, asshown) are coupled to a distal end of component 3071. Rotator 3080 isshaped to define one or more slits 3082 (e.g., 1 slit, as shown) througheach projects a first portion of a respective pin 3084 in order tocouple component 3071 to rotator 3080. Additionally, knob 3090 is shapedso as to define one or more slits 3085 (e.g., 1 slit, as shown) througheach projects a second portion of a respective pin 3084 during a pushedstate of knob 3070, as shown in FIG. 3A. Since the first and secondportions of pin 3084 are disposed within slits 3082 and 3085,respectively, pin 3084 mechanically couples knob 3090 to rotator 3080during the pushed state of knob 3070, as shown in FIG. 3A.

A distal portion of rotator 3080 is coupled, e.g., welded, to a proximalportion of torque-delivering-tool 26 such that rotation of rotator 3080(e.g., by knob 3090) rotates torque-delivering tool 26, andresponsively, manipulator 3040 and screwdriver head 3042 are rotated,and, in turn, spool 3046 is rotated. Thus, rotation of knob 3090 rotatesspool 3046. During rotation of knob 3090, torque-delivering tool 26 isrotated relative to overtube 90 and shaft 22 (that is, overtube 90 andshaft 22 are not rotated responsively to the rotation of tool 26). Insuch a manner, spool 3046 is rotated within housing 3342, while housing3342 and anchor 50 are not rotated.

It is to be noted that implantation of tissue anchor 50 and thesubsequent rotation of spool 3046 occur during a single advancement oftool 3022 within heart 2. Additionally, implantation of tissue anchor 50and the subsequent rotation of spool 3046 typically occur along a singleaxis of rotation, i.e., axis 3300 of tool 3022. That is, tool 3022remains along and is not moved away from (e.g., left, right, back, orforth) the axis of rotation during the rotation of spool 3046 followingthe screwing to tissue anchor 50 in order to implant tissue anchor 50.Furthermore, implantation of tissue anchor 50 and the subsequentrotation of spool 3046 typically occur without extracting at least thedistal end of tool 3022 from within heart 2 of the patient. That is,implantation of tissue anchor 50 and the subsequent rotation of spool3046 typically occur during a single advancement of tool 3022.

Reference is now made to FIGS. 1 and 3A-B. Knob 3070 is shaped to definea groove 3073 (as shown in FIG. 1 ). A flexible, semi-rigid release clip3072 is coupled to knob 3070 and is disposed within groove 3073. Clip3072 is shaped to define male couplings 3074 at respective distal endsof clip 3072. Couplings 3074 function to lock knob 3070 with respect tohandle portion 3026 during a pushed state of knob 3070 (FIG. 3A). FIG.3A shows knob 3070 in a pushed state in which (1) the proximal portionof component 3071 is disposed within the lumen of rotator 3080, (2) pin3084 is disposed at a distal end of slit 3082 of rotator 3080 and at adistal end of slit 3085 of knob 3090, and (3) male couplings 3074 aredisposed, and locked in place within respective female couplings 3081 ofrotator 3080. The coupling of male and female couplings 3074 and 3081,respectively, enable knob 3070 to remain in a locked position. FIG. 3Bshows knob 3070 following the proximal release of knob 3070 alongcentral axis 3300 of tool 3022, in which a proximal portion of component3071 is exposed proximal to lumen 3077 of rotator 3080, couplings 3074are disposed proximally to the opening of rotator 3080, and pin 3084 isdisposed in a proximal position within slit 3082 of rotator 3080 (and nolonger within slit 3085 of knob 3090).

The pushed state of knob 3070 compresses and applies load to a tensionspring 3078 that is disposed within knob 3070 and component 3071. Asshown in FIG. 3A, a proximal end of elongate locking mechanism releaserod 3060, is coupled to release rod holder 3061, which is coupled tocomponent 3071. Pushing distally of knob 3070 (and thereby component3071) advances holder 3061 distally, which, in turn, pushes distallyrelease rod 3060. Release rod 3060 extends through tool 3022 from handleportion 3026 and toward distal portion 3028 of tool 3022, and issurrounded, for the most part, by torque-delivering tool 26. During aresting state of tool 3022 (i.e., when knob 3070 is not pushed distally,as shown in FIG. 3B), a distal end 3062 of rod 3060 is disposed withintorque-delivering tool 26 proximally to and does not engage adjustingmechanism 40 (as shown in the enlarged image of FIG. 3B).

It is to be noted that in order to release locking mechanism 45 fromspool 3046, protrusion 156 should be pushed distally by rod 3060 between0.3 and 1.0 mm, e.g., 0.4 mm. When tool 3022 is decoupled from adjustingmechanism 40 and knob 3070 is disposed in a pushed state, the distal endportion of rod 3060 extends approximately 5 mm beyond the distal end oftool 3022. When adjusting mechanism 40 is coupled to tool 3022, and rod3060 is pushed distally (as shown in FIG. 3A), distal end 3062 of rod3060 contacts and is impeded by depressible portion 128 of lockingmechanism 45. Depressible portion 128 is capable of being depressed byan angle of up to 20 degrees, e.g., 7 degrees (i.e., cap 44 restrictsdepressing of portion 128 beyond a certain angle). When distal end 3062of rod 3060 contacts portion 128, portion 128 restricts rod 3060 fromextending further than 1 mm from second opening 182 of spool 3046. Inorder to compensate for the restricting of the extension of rod 3060beyond a predetermined amount, spring 3078 contracts in order toslightly pull back rod 3060. Spring 3078 thus enables tool 3022 to begenerally exacting in pushing protrusion 156 distally by 0.3-0.5, e.g.,0.4 mm.

Reference is again made to FIGS. 1 and 3A-B. In response to the pushingof knob distally, release rod 3060 slides distally within a lumen oftorque-delivering tool 26 such that a distal portion of rod 3060 slidesthrough lumen 3044 of manipulator 3040 (lumen 3044 is shown in theenlarged image of FIG. 3A), through screwdriver head 3042, and thenthrough a channel of spool 3046. A distal end 3062 of rod 3060 advancesthrough the channel of spool 3046, beyond the opening provided by lowersurface 152 of spool 3046, and presses distally on depressible portion128 of locking mechanism 45. Since depressible portion 128 is connectedto protrusion 156, pushing distally on depressible portion 128 pushesprotrusion 156 distally from within recess 154 of spool 3046, therebyfreeing spool 3046 from locking mechanism 45 (as shown in FIG. 3A). Asprotrusion 156 is pushed, it advances distally within recessed portion144 of cap 44 and away from recessed portion 142 of housing 3342.

It is to be noted that any elongate structure, e.g., a pull-wire, a rod,a thread, rope, or a suture, may be passed through the lumen oftorque-delivering tool 26 independently of and/or in addition to rod3060. It is to be noted that any elongate structure, e.g., a pull-wire,a rod, a thread, rope, or a suture, may be passed through the lumen ofshaft 22 independently of and/or in addition to tool 26.

Typically, tool 26 comprises a flexible material (e.g., a plastic or aplurality of strands of flexible metal such as stainless steel 304 thatare bundled together). Once protrusion 156 is displaced from withinrecess 154 of spool 3046, and spool 3046 is released from lockingmechanism 45, the physician rotates knob 3090 in a first directionthereof in order to rotate spool 3046, as described hereinabove. Tool3022 is free to rotate spool 3046 in either clockwise orcounterclockwise direction, as long as protrusion 156 of lockingmechanism 45 is decoupled from spool 3046. The physician is able tofreely rotate knob 3090 (and thereby spool 3046) without any obstructionfrom locking mechanism 45 because locking mechanism 45 is kept in anunlocked state (i.e., protrusion 156 remains outside of the recesses 154of spool 3046) due to the pushed state of knob 3070 of tool 3022. Duringthis pushed state, knob 3070 is maintained in a pushed state as malecouplings 3074 are coupled to female couplings 3081, and rod 3060 ismaintained in a state in which distal end 3062 is disposed distally tothe opening provided by lower surface 152 of spool 3046 and pushes ondepressible portion 128 of locking mechanism 45, as shown in theenlarged image of FIG. 3A.

Reference is again made to FIGS. 1 and 3A-B. As described hereinabove,the pushed state of knob 3070 (as shown in FIG. 3A) releases lockingmechanism 45 from spool 3046. Additionally, the pushed state of knob3070 engages the rotating mechanism of tool 3022 (which comprisesrotator 3080) with knob 3090. In a resting state of tool 3022, as shownin FIG. 3B, knob 3070 is disposed in its proximal-most position and pin3084 is disposed within slit 3082 of rotator 3080 proximally to knob3090. As shown in FIGS. 3A-B, knob 3090 is shaped to define slit 3085along a portions of the inner wall thereof that defines a lumen in whicha distal portion of rotator 3080 is disposed.

Slit 3082 of rotator 3080 enables slidable advancement of pin 3084during the distal sliding of component 3071 within lumen 3077 of rotator3080 responsively to pushing and pulling of knob 3070. During theresting state of tool 3022, as shown in FIG. 3B, knob 3070 is notpushed, and a proximal portion of component 3071 is exposed from withinlumen 3077 of rotator 3080. Pin 3084 is disposed proximally to knob3090, as shown in the enlarged image of FIG. 3B. During the pushed stateof knob 3070, pin 3084 is disposed at a distal end of slit 3082 ofrotator 3080 and at a distal end of slit 3085 of knob 3090.

Pin 3084 passes through slit 3085 of knob 3090. In an un-pushed state ofknob 3070, as shown in FIG. 3B, pin 3084 is disposed proximally to theproximal end of slit 3085. In the pushed state of knob 3070, as shown inFIG. 3A, pin 3084 is disposed within respective slit 3085 of knob 3090.It is to be further noted that tool 3022 comprises one pin 3084 by wayof illustration and not limitation, and that any suitable number of pins3084 may be coupled to tool 3022 in accordance with the number of slits3085. For example, if tool 3022 has 4 slits 3085, then tool 3022 maycomprise between 1 and 4 pins 3084.

In the pushed state of knob 3070, since knob 3090 is coupled to rotator3080, (and spool 3046 is now freed from locking mechanism due to thepushed state of knob 3070, as described hereinabove) rotation of knob3090 in a first direction thereof (i.e., counterclockwise), rotatesspool 3046 in the first direction and winds longitudinal member 60around spool 3046. Once freed from locking mechanism 45, manipulator3040 of tool 3022 can rotate spool 3046 bidirectionally. Rotation ofknob 3090 in a second direction (i.e., clockwise) opposite the firstdirection rotates spool 3046 in the opposite direction and unwindslongitudinal member 60 from around spool 3046.

Reference is yet again made to FIGS. 1 and 3A-B. Tool 3022 is shaped todefine a helical groove 3092 that is shaped to define an indented track3095. As described hereinabove, knob 3090 is coupled to the rotationmechanism of tool 3022, because pin 3084 couples rotator 3080 to knob2090 in the pushed state of knob 3070 when pin 3084 is disposed withinslit 3085 of knob 3090 (as shown in FIG. 3A). Knob 3090 is coupled at adistal end thereof to a tiered, or terraced, screw 3094, as shown inFIGS. 3A-B. A narrow end portion of screw 3094 is disposed within aportion of track 3095 and is helically advanceable distally andproximally responsively to rotation of knob 3090. FIG. 3A shows tool3022 prior to rotation of knob 3090 in the first direction, in whichscrew 3094 is disposed in a proximal portion of track 3095 of helicalgroove 3092.

Knob 3090 is coupled at a distal end 3091 thereof to a sliding indicator3100 which is shaped to define a window 3102 (shown in FIG. 1 ).Rotation of knob 3090 in the first direction helically advances screw3094 distally. This motion pushes linearly and distally slidingindicator 3100. Sliding indicator 3100 slides distally and proximallyalong a cylindrical body component 3106 responsively to rotation of knob3090 in first and second directions, respectively. Component 3106displays a series of numbers 3104. As indicator 3100 slides alongcomponent 3106, window 3102 displays one or a portion of one or more ofnumbers 3104, in order to indicate the number of rotations of spool3046. Numbers 3104 provide, by way of illustration and not limitation,numbers −3 to 4. Typically, in a resting state of tool 3022, indicator3100 is disposed at a middle section of groove 3092 in which window 3102displays the number 0 in the series of numbers 3104.

In the resting state (i.e., the 0-state of spool 3046) of contractingmechanism 40, longitudinal member 60 is wound around spool 3046 threetimes, as shown in the enlarged cross-sectional image of FIG. 3A. Thiswinding provides excess slack to member 60 (in case portions 60A and 60Bare coupled too tightly to leaflet 12). If the physician wishes toprovide slack to member 60, the physician unwinds a portion of member 60from around spool 3046. In order to accomplish such unwinding, thephysician rotates knob 3090 in the second direction thereof, i.e.,opposite the first direction. During the rotation of knob 3090 in thesecond direction, screw 3094 advances helically proximally along groove3092 and indicator 3100 displays the negative numbers. In the 0-state ofspool 3046 and in the unwound state of member 60, portions 60A and 60Bare slackened, as shown in FIG. 3A. When indicator 3100 is slid distallyand window 3102 reaches −3, member 60 is fully unwound from spool 3046.Since member 60 is looped through spool 3046, in the −3 state of spool3046 when member 60 is not wound around spool 3046, the physician canpull the free ends of portions 60A and 60B so as to adjust or make evenportions 60A and 60B that extend from spool 3046.

When the physician wishes to tighten member 60 (i.e., to tighten theartificial chord), the physician winds a portion of member 60 aroundspool 3046. In order to accomplish such winding, the physician rotatesknob 3090 in the first direction thereof, i.e., opposite the seconddirection. During such rotation of knob 3090 in the first direction,screw 3094 advances distally helically along groove 3092 and indicator3100 advances toward the positive numbers of numbers 3104. As shown inthe enlarged cross-sectional image of FIG. 3B, member 60 is wound aroundspool a total of 7 times, i.e., 4 winds of member 60 around spool inaddition to the 3 winds of member 60 at the 0-state of spool 3046. Asshown in FIG. 3B and in FIG. 4 , as spool 3046 is wound in the firstdirection and member 60 is wound sufficiently around spool 3046,portions 60A and 60B of member 60 are pulled taut.

Reference is now made to FIGS. 1 and 3A. The proximal annular portion ofsliding indicator 3100 is shaped so as to define a plurality of teeth3093. Knob 3090 is coupled to and houses at a distal end 3091 thereof aplunger 3097 (shown in FIG. 1 ). As knob 3090 is rotated, plunger 3097rotates along teeth 3093 of the proximal annular portion of indicator3100 and thereby provides an audible indication of the number of timesthe physician rotates knob 3090.

Reference is now made to FIG. 3B, which is a schematic illustration oftool 3022 following rotation of knob 3090, in accordance with someapplications of the present invention. As described hereinabove, knob3090 is rotated in the first direction in order to helically advancescrew 3094 distally along track 3095 of helical groove 3092.

Reference is now made to FIGS. 1 and 3A-B. Helical groove 3092 is shapedto define a certain number of rotations (e.g., 7, as shown by way ofillustration and not limitation in the figures). A distal end 3096 ofgroove 3092 (shown in FIG. 1 ) provides a termination point at whichscrew 3094 is restricted from being advanced further distally, androtation of knob 3090 in the first direction is thereby restricted.Restriction of rotation of knob 3090 beyond a predetermined pointrestricts rotation of spool 3046 beyond a predetermined amount ofrotations, e.g., 4 additional rotations from the 0-state of spool 3046),as shown by way of illustration and not limitation. It is to be notedthat because knob 3070 is also coupled to rotator 3080, rotation of knob3070 also facilitates rotation of spool 3046. However, rotation of spool3046 via knob 3070 does not rotate screw 3094 along groove 3092, andthereby rotation of spool 3046 is not restricted nor indicated byindicator 3100. Alternatively, rotation of spool 3046 using knob 3090 is(1) eventually restricted by the distal end of groove 3092, and (2)indicated by sliding indicator 3100. Therefore, rotation of spool 3046is typically but not necessarily performed responsively to rotation ofknob 3090.

As knob 3090 is rotated, it advances together with indicator 3100distally along body component 3106 of tool 3022.

Following rotation of spool 3046 (typically but not necessarilyresponsively to the rotation of knob 3090), screw 3094 is disposed at adistal end of groove 3092 (e.g., near or at distal end 3096 of groove3092), and indicator 3100 is disposed at a distal position in whichwindow 3102 approaches the distal-most number (i.e., number 4) in theseries of numbers 3104, indicating (1) that spool 3046 has been rotatedabout 4 times from its 0-state, (2) that longitudinal member 60 has beenwound around spool 3046 about an additional 4 times from its 0-state,and/or (3) the level of contraction of the portions 60A and 60B oflongitudinal member 60 that is coupled to adjusting mechanism 40.

Reference is now made to FIGS. 3A-B. Rotation of knob 3090 in the firstdirection, and thereby of spool 3046 in the first direction, winds alongitudinal member 60 around spool 3046. As described herein, rotationof knob 3090 in the second direction opposite the first directionadvances screw 3094 proximally along groove 3092, and rotates spool 3046in the second direction thereof. Winding of spool 3046 in the seconddirection unwinds longitudinal member 60 from around spool 3046 inaccordance with the number of rotations of knob 3090 in the seconddirection.

Following rotation of spool 3046 and adjustment of the length of theartificial chordae, tool 3022 is decoupled from adjusting mechanism 40.FIG. 3A shows knob 3070 in a pushed state in which male couplings 3074of clip 3072 are locked in place within female couplings 3081 of rotator3080. Additionally, in the pushed state of knob 3070, spring 3078 iscompressed. In order to lock spool 3046 in place following rotation ofspool 3046 following a desired level of rotation of spool 3046 (e.g., inresponse to a desired level of contraction of portions 60A and 60B oflongitudinal member 60), the operating physician pushes inwardly thelateral portions of clip 3072 coupled to knob 3070 in order to releaseknob 3070 from its pushed state. Male couplings 3074 of clip 3072 arepushed inwardly within groove 3073 as the lateral portions of clip 3072are pushed toward central axis 3300 of tool 3022. This pushing of malecouplings 3074 inwardly frees male couplings 3074 from within respectivefemale couplings 3081 (shown in FIG. 3B). Responsively, spring 3078expands from its compressed state, and knob 3070 is pushed proximally inresponse to the force of spring 3078.

As spring 3078 expands, it pulls proximally release rod holder 3061 andrelease rod 3060 coupled thereto. As rod 3060 is pulled proximally, itslides proximally within the lumen of torque-delivering tool 26 suchthat distal end 3062 of rod 3060 no longer pushes distally depressibleportion 128 of locking mechanism 45 (as shown in the enlargedcross-sectional image of FIG. 3B). Responsively to the retractingproximally of rod 3060, depressible portion 128 returns to its restingstate (i.e., not its pushed state, as shown in FIG. 3A) and therebyreturns protrusion 156 into one of the recesses 154 of spool 3046 andback into recessed portion 142 of housing 3342. Once protrusion 156 isplaced in recess 154 of spool 3046, spool 3046 is locked in place bylocking mechanism 45 and is restricted from being rotated by tool 3022.

As knob 3070 is released, knob 3070 is responsively pushed proximallyfrom the proximal end of knob 3090 by expansion of spring 3078. As knob3070 advances proximally, component 3071 that is coupled to knob 3070slides proximally within lumen 3077 of rotator 3080 and pin 3084 slidesproximally along slit 3082 of rotator 3080 and along slit 3085 of knob3090 (as shown in FIG. 3B).

The physician then rotates knob 3070 in order to unscrew screwdriverhead 3042 from threaded portion 2046 of spool 3046. Rotation of knob3070 rotates torque-delivering tool 26, as described hereinabove, whichrotates manipulator 3040. Unscrewing screwdriver head 3042 from spool3046 decouples manipulator 3040 from spool 3046. It is to be noted thatspool 3046 is not rotated during the rotation of knob 3070 in order todecouple manipulator 3040 from spool 3046 because spool 3046 is lockedin place by locking mechanism 45. The physician then pulls proximallytool 3022 in order to release housing 3342 of adjusting mechanism 40from graspers 3330 of adjusting mechanism holder 3029, and therebydecouple tool 3022 from adjusting mechanism 40.

Once tool 3022 is disengaged from adjusting mechanism 40 following theadjusting of the dimension of the artificial chordae tendineae, andthereby of leaflet(s) 12 or 14 of valve 8, tool 3022 is extracted fromthe heart. Holder 3029 is shaped so as to define a cone-shaped proximalportion which acts as an obturator to enlarge the opening surrounded bythe purse-string stitch. This shape enables ease and atraumaticextracting of distal portion 3028 of tool 3022. Following the extractingof tool 3022, the opening in the heart is closed, e.g., sutured, and theaccess site to the body of the patient is sutured.

If the physician wishes to recouple tool 3022 to adjusting mechanism 40following the decoupling of tool 3022 from adjusting mechanism 40, thephysician should rotate knob 3070 in order to recouple screwdriver head3042 with threaded portion 2046 of spool 3046. As the operatingphysician rotates knob 3070, structural component 3071 rotates and,since component 3071 is coupled to rotator 3080 via pin 3084, rotator3080 rotates responsively to rotate torque-delivering tool 26 andthereby manipulator 3040.

Delivery tool 3022 is recoupled to mechanism 40 when graspers 3330 ofholder 3029 surround projection 3346 of spool 3046, which providesinitial coupling of tool 3022 to adjusting mechanism 40. During theinitial coupling, manipulator 3040 may be pushed proximally, alongcentral axis 3300 of tool 3022, by the force of contact of adjustingmechanism 40 to tool 3022. Manipulator 3040 is coupled to a distal endof torque-delivering tool 26, which in turn, is coupled at a proximalend thereof to torque-delivering-tool rotator 3080. Torque-deliveringtool 26 slides within overtube 90 which is disposed within a primarylumen 190 of shaft 22 (as shown in the cross-sectional illustration ofFIG. 2 ). Tool 3022 enables such proximal pushing of manipulator 3040 byproviding a tensile spring 3087 (shown in FIGS. 1 and 3A-B) around aproximal portion of rotator 3080 that is coupled to torque-deliveringtool 26. As screwdriver head 3042 contacts adjusting mechanism 40,adjusting mechanism 40 responsively pushes and slides proximally (1)screwdriver head 3042 (2) manipulator 3040, (3) torque-delivering tool26, and (4) rotator 3080. Responsively to the pushing oftorque-delivering-tool 26, spring 3087 is compressed to enable suchproximal sliding of (1) screwdriver head 3042 (2) manipulator 3040, (3)torque-delivering tool 26, and (4) rotator 3080.

Following the initial recoupling of adjusting mechanism 40 to tool 3022,tool 3022 is then more firmly coupled to adjusting mechanism 40 byscrewing screwdriver head 3042 into threaded portion 2046 (shown inFIGS. 3A-B) of spool 3046 of adjusting mechanism 40. By the screwing,screwdriver head 3042 is advanced distally toward adjusting mechanism40. This screwing of head 3042 is accomplished when the physicianrotates knob 3070 in the first direction (i.e., counterclockwise),which, in conjunction, rotates (1) component 3071, (2) rotator 3080, (3)torque-delivering tool 26, and finally, (4) screwdriver head 3042 ofmanipulator 3040. Responsively, screwdriver head 3042 screws intothreaded portion 2046 of spool 3046, and thereby, adjusting mechanism 40is firmly coupled to tool 3022. Once tool 3022 is firmly coupled toadjusting mechanism 40, tool 3022 (1) frees spool 3046 from lockingmechanism 45, and (2) rotates spool 3046, as described hereinabove.

Reference is now made to FIGS. 1, 2, 3A-B, and 4. It is to be noted thatthe method and apparatus for using the same delivery tool to both (1)facilitate screwing of the tissue anchor into tissue of the patient(while not facilitating rotation of rotatable structure 2900), and (2)subsequently rotate rotatable structure 2900, may be applied in apercutaneous or transcatheter procedure, mutatis mutandis.

For some applications, techniques described herein are practiced incombination with techniques described in one or more of the referencescited in the Background section and Cross-references section of thepresent patent application.

As appropriate, techniques described herein are practiced in conjunctionwith methods and apparatus described in one or more of the followingpatent applications, all of which are assigned to the assignee of thepresent application and are incorporated herein by reference:

-   -   PCT Publication WO 06/097931 to Gross et al., entitled, “Mitral        Valve treatment techniques,” filed Mar. 15, 2006;    -   U.S. Provisional Patent Application 60/873,075 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Dec. 5, 2006;    -   U.S. Provisional Patent Application 60/902,146 to Gross et al.,        entitled, “Mitral valve closure techniques,” filed Feb. 16,        2007;    -   U.S. Provisional Patent Application 61/001,013 to Gross et al.,        entitled, “Segmented ring placement,” filed Oct. 29, 2007;    -   PCT Publication WO 08/068756 to Gross et al., entitled,        “Segmented ring placement,” filed Dec. 5, 2007;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed Dec. 5, 2007, which        published as US 2008/0262609, and which issued as U.S. Pat. No.        8,926,695;    -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US        2010/0161041, and which issued as U.S. Pat. No. 8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as US 2010/0286767, and which        issued as U.S. Pat. No. 8,715,342;    -   PCT Publication WO 10/004546 to Gross et al., entitled,        “Annuloplasty devices and methods of delivery therefor,” filed        on Jun. 15, 2009;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Sep. 21, 2009, which published as US 2010/0161042 and which        issued as U.S. Pat. No. 8,808,368;    -   PCT Publication WO 10/073246 to Cabin et al., entitled,        “Adjustable annuloplasty devices and mechanisms therefor,” filed        Dec. 22, 2009;    -   U.S. patent application Ser. No. 12/706,868 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed Feb. 17, 2010,        which published as US 2010/0211166, and which issued as U.S.        Pat. No. 8,353,956;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed        May 4, 2010, which published as WO 2010/128502; and/or    -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,        entitled, “Deployment techniques for annuloplasty ring and        over-wire rotation tool,” filed May 4, 2010, which published as        WO 2010/128503.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. Apparatus, comprising: an implantcomprising: a tissue-adjusting member configured to be coupled tocardiovascular tissue of a patient, the tissue-adjusting membercomprising a longitudinal member; and a tissue anchor coupled to thetissue-adjusting member, wherein the tissue anchor comprises a helicalshape configured to be screwed into the cardiovascular tissue of thepatient; a tissue-coupling element coupled to the longitudinal member;and a delivery tool reversibly couplable to the implant, the deliverytool being configured to cardiovascular deliver the implant to thecardiovascular tissue of the patient, the delivery tool comprising: ahandle; an elongate shaft, extending distally away from the handle; atissue-coupling-element holder coupled to a portion of the elongateshaft distal from the handle, the delivery tool being configured todeliver the implant endovascularly to the cardiovascular tissue whilethe handle is outside the patient and the tissue-coupling-elementholder, disposed proximally from the tissue anchor, holds the tissuecoupling element; and an actuating element configured to screw thetissue anchor into the cardiovascular tissue by rotating the tissueanchor about an axis of rotation that is along a longitudinal axis ofthe delivery tool while not rotating the tissue-coupling-element holderwith respect to the shaft.
 2. The apparatus according to claim 1,wherein the tissue-adjusting member comprises one or more artificialchordae tendineae.
 3. The apparatus according to claim 1, wherein thetissue-coupling-element holder surrounds the portion of the elongateshaft.
 4. The apparatus according to claim 1, wherein thetissue-coupling-element holder is coupled to the portion of the elongateshaft in a manner in which pulling the tissue-coupling-element holderproximally facilitates pulling of the elongate shaft proximally.
 5. Theapparatus according to claim 1, wherein the tissue-coupling-elementholder is shaped so as to define a planar element.
 6. The apparatusaccording to claim 1, where the tissue-coupling element comprises aneedle, and wherein the tissue-coupling-element holder is shaped so asto define a slit for reversibly coupling the tissue-coupling element tothe tissue-coupling-element holder.
 7. The apparatus according to claim1, wherein the elongate shaft comprises a multi-lumen elongate shaft,and wherein, during the delivery of the implant to the cardiovasculartissue of the patient, the longitudinal member is disposed within asecondary lumen of the multi-lumen elongate shaft.
 8. The apparatusaccording to claim 7, wherein the secondary lumen is shaped so as todefine a slit that runs parallel to a longitudinal axis of the deliverytool, and wherein the longitudinal member is pullable away from thelongitudinal axis of the delivery tool via the slit in order to removethe longitudinal member from within the elongate shaft.
 9. The apparatusaccording to claim 1, wherein during the anchoring of the cardiovasculartissue anchor into the tissue of the patient, thetissue-coupling-element holder is configured to be accessible fromoutside of a body of the patient.
 10. A method, comprising: using adelivery tool, advancing an implant endovascularly to cardiovasculartissue and delivering the implant to cardiovascular tissue, the implantincluding (1) a tissue-adjusting member including a longitudinal member,and (2) a tissue anchor coupled to the tissue-adjusting member, thetissue anchor comprising a helical shape configured to be screwed intothe cardiovascular tissue, the tissue-adjusting member being coupled toa tissue-coupling element, the delivery tool including: a handle; anelongate shaft, extending distally away from the handle; atissue-coupling-element holder coupled to a distal portion of theelongate shaft, the tissue-coupling-element holder being configured tohold the tissue-coupling element during the delivering of the implant tothe cardiovascular tissue; and an actuating element configured to rotatethe tissue anchor about an axis of rotation that is along a longitudinalaxis of the delivery tool screwing the tissue anchor into thecardiovascular tissue by rotating the tissue anchor about the axis ofrotation by rotating the actuating element of the delivery tool whilenot rotating the tissue-coupling-element holder with respect to theshaft.
 11. The method according to claim 10, wherein thetissue-adjusting member includes one or more artificial chordaetendineae.
 12. The method according to claim 10, wherein thetissue-coupling-element holder surrounds the portion of the elongateshaft.
 13. The method according to claim 10, further comprising pullingof the elongate shaft proximally by pulling the tissue-coupling-elementholder proximally.
 14. The method according to claim 10, wherein duringthe anchoring of the tissue anchor into the cardiovascular tissue, thetissue-coupling-element holder is configured to be accessible fromoutside of a body of a patient, and wherein the method comprisesaccessing the tissue-coupling-element holder from outside the body ofthe patient.
 15. The method according to claim 10, further comprising:subsequently to the anchoring of the tissue anchor into thecardiovascular tissue, suturing the longitudinal member to thecardiovascular tissue using the tissue-coupling element; andsubsequently to the suturing, clipping the longitudinal member andremoving from a body of a patient (a) excess portions of thelongitudinal member, and (b) the tissue-coupling element.
 16. The methodaccording to claim 10, where the tissue-coupling element includes aneedle, wherein the tissue-coupling-element holder is shaped so as todefine a slit for reversibly coupling the tissue-coupling element to thetissue-coupling-element holder, and wherein the method further comprisesdecoupling the needle from the slit of the tissue-coupling-elementholder subsequently to the delivering of the implant.
 17. The methodaccording to claim 16, further comprising, subsequently to thedecoupling of the needle from the slit, suturing the longitudinal memberto the cardiovascular tissue using the needle.
 18. The method accordingto claim 10, wherein the elongate shaft comprises a multi-lumen elongateshaft, and wherein, during the delivering of the implant to thecardiovascular tissue, the longitudinal member is disposed within asecondary lumen of the multi-lumen elongate shaft.
 19. The methodaccording to claim 18, wherein the secondary lumen is shaped so as todefine a slit that runs parallel to a longitudinal axis of the deliverytool, and wherein the method further comprises removing the longitudinalmember from within the elongate shaft by pulling the longitudinal memberaway from the longitudinal axis of the delivery tool via the slit.